Browsing Tag
FDA clearance
20 posts
Singular Health (ASX: SHG) secures fast-track FDA clearance for 3DICOM MD Cloud, strengthening its U.S. commercial leverage
FDA clearance for Singular Health Limited’s 3DICOM MD Cloud opens the U.S. market. Find out what this means for imaging economics and competition.
Why Femasys’ FDA-cleared next-generation FemVue device could reshape non-radiation fertility diagnostics in the U.S.
Find out how Femasys’ FDA-cleared next-generation FemVue device could reshape non-radiation fertility diagnostics and influence the U.S. women’s health market today.
FDA clears Hyperfine’s Optive AI update as Swoop system adds advanced diffusion imaging for stroke care
Find out how FDA clearance of Hyperfine’s Optive AI update enhances stroke detection and strengthens the Swoop portable MRI platform.
Can Hugo give hospitals a smarter surgical robot? FDA clearance puts Medtronic to test
Medtronic gets U.S. FDA clearance for Hugo RAS system in urologic surgery, unlocking new competition in robotic-assisted soft-tissue procedures. Read more.
Will a2z Radiology AI’s unified model become the new gold standard for emergency imaging?
a2z Radiology AI’s unified triage system for abdominal CT gets FDA approval. Find out what this could mean for radiologists and hospital workflows in 2025.
FDA clears Stereotaxis GenesisX robotic system, paving way for next-gen precision in cardiac procedures
Discover how Stereotaxis’ GenesisX robotic system gained FDA approval and what it means for the future of cardiac robotics.
Jupiter Neurosciences secures FDA green light for Phase 2a clinical trial of JOTROL in Parkinson’s disease
Find out how Jupiter Neurosciences’ FDA-approved JOTROL Phase 2a trial could reshape Parkinson’s treatment and redefine the biotech innovation race.
Breakthrough: FDA grants NeurAxis first-ever clearance for adult functional dyspepsia pain and nausea
Discover how NeurAxis’s newly FDA-cleared PENFS therapy is changing treatment for adults with functional dyspepsia pain and nausea.
4DMedical’s CT:VQ clearance could mark the end of nuclear VQ scans—is the industry ready for software-first lung imaging?
4DMedical’s FDA-cleared CT:VQ may replace nuclear lung scans with software-powered diagnostics. Explore how this breakthrough is reshaping imaging standards.
GE HealthCare launches Vivid Pioneer: Can AI-powered ultrasound redefine cardiovascular imaging?
GE HealthCare launches Vivid Pioneer, its most advanced AI-powered cardiovascular ultrasound system. Explore how it could transform cardiac imaging.